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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Paclitaxel
Trade Name: Taxol
Date Designated: 03/25/1997
Orphan Designation: Treatment of AIDS-related Kaposi's sarcoma.
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Pharmaceutical Research Institute
5 Research Parkway
P.O. Box 5100
Wallingford, Connecticut 06492
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Paclitaxel
Trade Name: Taxol
Marketing Approval Date: 08/04/1997
Approved Labeled Indication: For the second line treatment of AIDS-related Kaposi's sarcoma.
Exclusivity End Date: 08/04/2004 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.